INTRODUCTION

FELBAN AL 40/240MG TABLET is a combination of Artemether and Lumefantrine which belongs to the group of medicines called Antimalarials. It is used in infants, children and adults for the treatment of acute uncomplicated malaria (mosquito borne disease with symptoms of fever with chills, tiredness, nausea, vomiting, stomach pain) caused by a parasite called plasmodium falciparum.

FELBAN AL 40/240MG TABLET should be used with caution in patients with severe liver or kidney problems or if the patient feels worse or unwell to eat and drink.

FELBAN AL 40/240MG TABLET is not recommended for use in patients having severe type of malarial infection affecting the lungs, kidney or brain, heart condition such as changes in the heart rhythm, slow heartbeat or severe heart disease and low levels of electrolytes such as potassium or magnesium in the blood.

FELBAN AL 40/240MG TABLET is generally not recommended for use during the first trimester of pregnancy and it should be used with caution during the second and third trimester of pregnancy and breast-feeding women only if advised by the doctor.

FELBAN AL 40/240MG TABLET should be used with caution in children and your child’s doctor may adjust the dose depending upon child’s age and body weight.

The most common side effects of taking FELBAN AL 40/240MG TABLET are headache, dizziness, vomiting, stomach pain, nausea, muscle pain and loss of appetite. Consult your doctor if any of the side effects worsen.

USES OF FELBAN AL 40/240MG TABLET

• Treats acute uncomplicated malarial infections (caused by plasmodium falciparum) in infants, children and adults

HOW FELBAN AL 40/240MG TABLET WORKS

FELBAN AL 40/240MG TABLET effectively treats malarial infections, where artemether effectively kills the malarial parasites by binding to haem (part of molecules that contains iron which is toxic to malarial parasites) which is produced during the breakdown of haemoglobin. Lumefantrine works by binding to hemin where it prevents the formation of a toxic malarial pigment called hemozoin, thereby it treats malarial infection. In addition to this artemether and lumefantrine blocks nucleic acid and protein synthesis in parasite that damages the parasitic cell membrane of plasmodium falciparum which leads to the death of parasite. Thus, it helps in treating the malarial infection.

DIRECTIONS FOR USE

Take FELBAN AL 40/240MG TABLET exactly as advised by your doctor.

For Tablet, Capsule: Swallow FELBAN AL 40/240MG TABLET with a glass of water. This medicine should be taken with food or drinks rich in fat such as milk. Crush the medicine into powder if your child is unable to swallow the whole medicine.

For Dispersible Tablet: Disperse FELBAN AL 40/240MG TABLET in the specified quantity of water as mentioned in the label. Consume the mixture immediately after reconstitution.

Your doctor will decide the correct dose and duration for you depending upon your age, body weight and severity of the disease condition.

SIDE EFFECTS OF FELBAN AL 40/240MG TABLET

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the forehead if required. Do not consume too much of alcohol. Consult your doctor if the symptom does not improve.

Nausea and vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.

Stomach pain:

Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom does not improve.

Diarrhea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom does not improve.

Tiredness:

Drink plenty of fluid and eat balanced diet and frequent meals. Do regular minimal exercise and follow regular sleep schedule. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

PREGNANCY

FELBAN AL 40/240MG TABLET is generally not recommended for use during the first trimester of pregnancy. It should be used with caution during second and third trimester of pregnancy only if considered clearly necessary. Consult your doctor before taking FELBAN AL 40/240MG TABLET.

BREASTFEEDING

FELBAN AL 40/240MG TABLET should be taken with caution in breast feeding women only if considered clearly necessary. Consult your doctor before taking FELBAN AL 40/240MG TABLET.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience dizziness, sleepiness or weakness after taking FELBAN AL 40/240MG TABLET.

KIDNEY

FELBAN AL 40/240MG TABLET is not recommended for use in patients having severe type of malarial infection affecting the kidneys. It should be taken with caution in patients with severe kidney problems. Consult your doctor before taking FELBAN AL 40/240MG TABLET.

LIVER

FELBAN AL 40/240MG TABLET should be taken with caution in patients with severe liver problems. Consult your doctor before taking FELBAN AL 40/240MG TABLET.

ALLERGY

Do not take FELBAN AL 40/240MG TABLET if you are allergic to Artemether, Lumefantrine or any other ingredients of this medicine.

LUNGS

FELBAN AL 40/240MG TABLET is not recommended for use in patients having malaria with pulmonary edema or severe type of malarial infection affecting the lungs. Consult your doctor before taking it.

HEART DISEASE

FELBAN AL 40/240MG TABLET is not recommended for use in patients with severe heart disease or with heart diseases such as slow heartbeat, changes in the rhythm or rate of the heartbeat or family history of death due to heart problems or born with heart problems. FELBAN AL 40/240MG TABLET should be taken with caution in patients with variations in ECG (prolongation of QTc interval). Consult doctor before taking FELBAN AL 40/240MG TABLET.

INTERACTIONS

A. Drug – drug interactions:

Before taking FELBAN AL 40/240MG TABLET, inform your doctor if you are taking any of the following medicines:

• medicines used to treat heart rhythm problems (Ex. Flecainide, metoprolol)
• medicines used to treat depression (Ex. imipramine, amitriptyline, clomipramine, St. John’s wort)
• medicine used to treat leprosy or tuberculosis (Ex. rifampicin)
• medicines used to treat bacterial infections (EX.  fluroquinolones such as ciprofloxacin, levofloxacin, macrolide antibiotics like azithromycin, erythromycin)
• medicines used to treat fungal infection (Ex. ketoconazole, fluconazole, itraconazole)
• medicines used to treat allergy (Ex. terfenadine, astemizole)
• medicine used to treat stomach disturbance (Ex. cisapride)
• medicines used to treat fits (Ex. carbamazepine, phenytoin)
• medicines used to treat malaria (Ex.  atovaquone/proguanil, chloroquine)
• medicines used to treat HIV infection (Ex. indinavir, ritonavir)
• medicine used to prevent pregnancy (Ex. Ethinyl estradiol)

B. Drug – Food interactions

Drink grapefruit juice with caution while taking FELBAN AL 40/240MG TABLET as it may interact with this medicine.

Overdosage:

If you or anyone else accidentally take too much of FELBAN AL 40/240MG TABLET, consult your doctor immediately or visit a nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep FELBAN AL 40/240MG TABLET out of reach of children
• Store FELBAN AL 40/240MG TABLET at room temperature

FAQs ABOUT FELBAN AL 40/240MG TABLET

What is FELBAN AL 40/240MG TABLET used for?

FELBAN AL 40/240MG TABLET is used in infants, children and adults for the treatment of acute uncomplicated malaria (mosquito born disease with symptoms of fever with chills, tiredness, nausea, vomiting, stomach pain) caused by a parasite called plasmodium falciparum.

Does FELBAN AL 40/240MG TABLET helps to prevent malaria?

FELBAN AL 40/240MG TABLET is not used to prevent malaria. It is only used to treat malarial infection caused by a parasite called plasmodium falciparum. Consult your doctor for advice before taking this medicine.

Is FELBAN AL 40/240MG TABLET safe to use in pregnant women?

FELBAN AL 40/240MG TABLET is generally not recommended for use during the first trimester of pregnancy. It should be used with caution during second and third trimester of pregnancy only if considered clearly necessary. Consult your doctor before taking FELBAN AL 40/240MG TABLET.

Can FELBAN AL 40/240MG TABLET be used in patients with kidney problems?

FELBAN AL 40/240MG TABLET is not recommended for use in patients having severe type of malarial infection affecting the kidneys. It should be taken with caution in patients with severe kidney problems. Consult your doctor before taking FELBAN AL 40/240MG TABLET.

Does FELBAN AL 40/240MG TABLET cause diarrhea?

Yes, FELBAN AL 40/240MG TABLET may cause diarrhea in some individuals. To manage this effect, drink lot of fluids such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom does not improve.

REFERENCES

1. KD Tripathi. Antimalarial drugs. Essentials of Medical Pharmacology. Eighth edition. 2019. Page: 875-77.

2. Stephan Ehrhardt, Christian G Meyer. Artemether–lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria. NIH. National Library of medicine. National center for Biotechnology Information. PubMed central. October 2009. [Accessed on 3rd November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2762439/

3. Novartis Pharmaceuticals. Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (CALINA). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in March 2020] [Accessed on 3rd November 2022] https://clinicaltrials.gov/ct2/show/NCT04300309

4. Novartis Ireland Limited. Electronic Medicines Compendium (EMC). [Revised in August 2021] [Accessed on 3rd November 2022] https://www.medicines.org.uk/emc/files/pil.1628.pdf

5. Ajanta Pharma Ltd. Food and Drugs Authority (FDA).[Revised in February 2018] [Accessed on 3rd November 2022] https://fdaghana.gov.gh/img/smpc/Artefan%20(Artemether-Lumefantrine%2060mg-360mg)%20Tablets.pdf

6. Ajanta Pharma Ltd. Artefan 80/480 (Artemether and Lumefantrine). [Revised in March 2019] [Accessed on 3rd November 2022] https://extranet.who.int/pqweb/sites/default/files/MA130part3.pdf

7. Ajanta Pharma Ltd. Artefan 40/240 (Artemether and Lumefantrine). [Revised in March 2019] [Accessed on 3rd November 2022] https://extranet.who.int/pqweb/sites/default/files/MA128part3.pdf

8. Getz pharma ltd. Artheget (Artemether + Lumefantrine). [Accessed on 3rd November 2022] https://getzpharma.com/wp-content/uploads/2016/07/Artheget-Range-Leaflet-Pakistan.pdf

9. Cipla Ltd. Lumet 80 Tablets (Artemether + Lumefantrine). CiplaMed. [Revised in October 2013] [Accessed on 3rd November 2022] https://ciplamed.com/content/lumet-80-tablets

USEFUL DIAGNOSTIC TESTS

• Peripheral Smear for Malaria

AUTHOR DETAILS

Written By Dr. R. Dinesh John Rajkumar, Pharm.D
Last updated on 12 Nov 2022 | 10:34 AM(IST)